The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- July 16, 2012
- Posted
- December 7, 2012
- Terminated
- July 22, 2015
- Recall Number
- Z-0489-2013
- Quantity
- 77 units
- Firm Location
- Branchburg, NJ
Reason for Recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Distribution
Nationwide Distribution
Lot / Code Info
Device-associated diagnostic software
Root Cause
Software design
Action Taken
Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.